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Study of the Safety and Efficacy of RGH-896 in Patients With Diabetic Peripheral Neuropathic Pain

Primary Purpose

Diabetic Peripheral Neuropathic Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RGH-896
RGH-896
RGH-896
pregabalin
placebo
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathic Pain focused on measuring diabetic, peripheral, neuropathic, pain, chronic, diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female outpatients 18 to 75 years of age
  • A diagnosis of painful diabetic neuropathy
  • Controlled blood glucose
  • Willingness to wash out all analgesic medications used for DPNP
  • Female patients either postmenopausal, surgically sterile, or practicing a medically acceptable method of contraception
  • Female patients who are not pregnant

Exclusion Criteria:

  • Acute infections or cardiac problems
  • Past use of pregabalin
  • History of severe psychiatric disorder
  • History of any amputation due to diabetes
  • History of seizure disorder
  • Active diabetic foot ulcers

Sites / Locations

  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
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  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

1

2

3

4

5

Arm Description

Outcomes

Primary Outcome Measures

Change in mean daily pain rating

Secondary Outcome Measures

50% reduction in pain

Full Information

First Posted
February 5, 2009
Last Updated
July 6, 2011
Sponsor
Forest Laboratories
Collaborators
Gedeon Richter Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00838799
Brief Title
Study of the Safety and Efficacy of RGH-896 in Patients With Diabetic Peripheral Neuropathic Pain
Official Title
A Randomized, Double-Blind, Placebo- and Active-Controlled Study of the Safety and Efficacy of RGH-896 in Patients With Diabetic Peripheral Neuropathic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Forest Laboratories
Collaborators
Gedeon Richter Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to evaluate the safety and efficacy of RGH-896 in patients with diabetic peripheral neuropathic pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathic Pain
Keywords
diabetic, peripheral, neuropathic, pain, chronic, diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
458 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Active Comparator
Arm Title
5
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
RGH-896
Intervention Description
45 mg TID, capsules, 14 weeks.
Intervention Type
Drug
Intervention Name(s)
RGH-896
Intervention Description
30 mg TID, capsules, 14 weeks.
Intervention Type
Drug
Intervention Name(s)
RGH-896
Intervention Description
15 mg TID, capsules, 14 weeks.
Intervention Type
Drug
Intervention Name(s)
pregabalin
Other Intervention Name(s)
Lyrica
Intervention Description
100 mg, TID, capsules, 14 weeks.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
TID, capsules, 14 weeks.
Primary Outcome Measure Information:
Title
Change in mean daily pain rating
Time Frame
Baseline to Week 14
Secondary Outcome Measure Information:
Title
50% reduction in pain
Time Frame
Baseline to Week 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female outpatients 18 to 75 years of age A diagnosis of painful diabetic neuropathy Controlled blood glucose Willingness to wash out all analgesic medications used for DPNP Female patients either postmenopausal, surgically sterile, or practicing a medically acceptable method of contraception Female patients who are not pregnant Exclusion Criteria: Acute infections or cardiac problems Past use of pregabalin History of severe psychiatric disorder History of any amputation due to diabetes History of seizure disorder Active diabetic foot ulcers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allyson Gage, PhD
Organizational Affiliation
Forest Research Institute, a subsidiary of Forest Laboratories Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
Forest Investigative Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
Forest Investigative Site
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Forest Investigative Site
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Forest Investigative Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Forest Investigative Site
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72114
Country
United States
Facility Name
Forest Investigative Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Forest Investigative Site
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Forest Investigative Site
City
Lakewood
State/Province
California
ZIP/Postal Code
90712
Country
United States
Facility Name
Forest Investigative Site
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Forest Investigative Site
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Forest Investigative Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Forest Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92117
Country
United States
Facility Name
Forest Investigative Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Forest Investigative Site
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Forest Investigative Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Forest Investigative Site
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Forest Investigative Site
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Forest Investigative Site
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
Forest Investigative Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34203
Country
United States
Facility Name
Forest Investigative Site
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Forest Investigative Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Forest Investigative Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33023
Country
United States
Facility Name
Forest Investigative Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Forest Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33108
Country
United States
Facility Name
Forest Investigative Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Forest Investigative Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Forest Investigative Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Forest Investigative Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Forest Investigative Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Forest Investigative Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Forest Investigative Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
Facility Name
Forest Investigative Site
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Forest Investigative Site
City
Owings Mills
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States
Facility Name
Forest Investigative Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Forest Investigative Site
City
West Caldwell
State/Province
New Jersey
ZIP/Postal Code
07006
Country
United States
Facility Name
Forest Investigative Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Forest Investigative Site
City
New York
State/Province
New York
ZIP/Postal Code
10004
Country
United States
Facility Name
Forest Investigative Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Forest Investigative Site
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Forest Investigative Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Forest Investigative Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Forest Investigative Site
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Forest Investigative Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Forest Investigative Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Forest Investigative Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Forest Investigative Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Forest Investigative Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Forest Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Forest Investigative Site
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
Forest Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Forest Investigative Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Forest Investigative Site
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Forest Investigative Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of the Safety and Efficacy of RGH-896 in Patients With Diabetic Peripheral Neuropathic Pain

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